- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00317304
Mindfulness Based Stress Reduction for Hot Flashes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The majority of women experience vasomotor symptoms (VMS) such as hot flashes (HF) and night sweats as they transition through menopause, and a substantial minority experience considerable distress and diminished role functioning. Until recently most women found relief through hormone therapy (HT), but concern about the health risks associated with HT has left women with few effective and safe choices for relief from their symptoms other than their own coping strategies. A variety of results from both population and laboratory studies suggest that stress and HF are correlated and that HF are more severe in women with lower coping abilities, but evidence is far from conclusive. Consequently, investigators have called for trials to evaluate the effect of stress reduction interventions on HF. Mindfulness-Based Stress Reduction (MBSR) is a widely available manualized program shown to be an effective adjunctive intervention in reducing medical symptoms and psychological distress for a wide range of stress-related disorders. In a small preliminary study using MBSR we found reductions in HF severity scores and increases in menopause-related quality of life (QOL). This R21 proposal is for a pilot randomized trial of MBSR compared to a wait-list control group for 120 menopausal women experiencing seven or more HF/day of moderate to severe intensity. It aims to:
- assess feasibility of recruitment, adherence to program intervention, and compliance with assessment instruments in preparation for a larger RCT; and
- provide preliminary estimates of efficacy of the effects of MBSR in reducing self-reported HF frequency and intensity and improving QOL.
In addition, we will use sternal skin conductance as an established objective measure of VMS in a subgroup of 15 women in each arm to test feasibility and obtain information on how objectively measured HF are related to self-reported HF in this setting. Women will be assessed at baseline, at the end of the eight-week MBSR course, and at three months after the end of the course. A secondary aim is to explore whether treatment group differences of HF frequency and intensity and QOL are explained by changes in perceived stress, health-related locus of control and mindfulness. It is anticipated that results from this pilot study will provide data needed to plan a larger more definitive randomized trial on the effect of MBSR on HF frequency and intensity and on the ability to cope with these symptoms.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01655
- University of Massachusetts Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Average of 5+ hot flashes per day
- No menses in prior 3 months
- Ages between 40 and 69 years
- English speaking
- Access to a telephone
- Availability for the entire study period
- Agree to maintain usual diet
- Agree to maintain usual exercise habits
- Consent to the study
Exclusion Criteria:
- Psychiatric illness
- Illness with less than one year life expectancy
- Alcohol use ≥ 2 drinks per day
- Current substance abuse or addiction
- Use of selective estrogen receptor modulator (SERM) medications within the past 3 months
- Use of HT within the past 3 months
- Currently pregnant or breastfeeding
- Ongoing mindfulness meditation practice
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MBSR
|
MBSR is an 8-week group-based program of training in mindfulness and its application to the stresses and challenges of everyday life
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hot flash frequency and intensity
Time Frame: Baseline, 8 weeks, 24 weeks
|
Baseline, 8 weeks, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Menopause-related quality of life
Time Frame: Baseline, 8 weeks, 24 weeks
|
Baseline, 8 weeks, 24 weeks
|
Hot Flash-Related Daily Interference Scale
Time Frame: Baseline, 8 weeks, 24 weeks
|
Baseline, 8 weeks, 24 weeks
|
Women's Health Initiative (WHI) Insomnia Rating Scale
Time Frame: Baseline, 8 weeks, 24 weeks
|
Baseline, 8 weeks, 24 weeks
|
5 factor of Mindfulness questionnaire
Time Frame: Baseline, 8 weeks, 24 weeks
|
Baseline, 8 weeks, 24 weeks
|
Health locus of control
Time Frame: Baseline, 8 weeks, 24 weeks
|
Baseline, 8 weeks, 24 weeks
|
Perceived stress
Time Frame: Baseline, 8 weeks, 24 weeks
|
Baseline, 8 weeks, 24 weeks
|
Dietary intake
Time Frame: Baseline, 8 weeks, 24 weeks
|
Baseline, 8 weeks, 24 weeks
|
Compliance with intervention conditions
Time Frame: Baseline, 8 weeks, 24 weeks
|
Baseline, 8 weeks, 24 weeks
|
HADS
Time Frame: Baseline, 8 weeks, 24 weeks
|
Baseline, 8 weeks, 24 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: James Carmody, PhD, University of Massachusetts, Worcester
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT002910-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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